Effectiveness and Tolerability of the Single-Pill Combination of Bisoprolol and Perindopril in Patients with Arterial Hypertension and Stable Coronary Artery Disease in Daily Clinical Practice: The STYLE Study

Abstract

Introduction: Combination antihypertensive therapy is required by most patients to achieve guideline-recommended blood pressure (BP) goals. This study assessed the effectiveness and tolerability of bisoprolol/perindopril (Bis/Per) single-pill combination (SPC) in Russian patients with hypertension and coronary artery disease (CAD) treated in routine clinical practice. Methods: STYLE (NCT03730116) was an openlabel, uncontrolled, prospective observational study conducted in patients who were already receiving Bis/Per SPC, switched to SPC from Bis or Per monotherapy, or switched from a free combination of Bis and Per. Primary endpoint criteria were assessed at 1 and 3 months and included change in mean office systolic/diastolic blood pressure (SBP/DBP), proportion achieving target BP (\ 140/90 mmHg), and measures of antianginal effectiveness. Results: The full analysis set comprised 1892 subjects. Mean age was 61.9 ± 8.8 years, 53.2% were women, and mean durations of hypertension and CAD were 12.5 ± 7.9 and 7.2 ± 6.4 years, respectively. Mean SBP/DBP decreased by 22.3/11.0 mmHg and 31.5/ 15.9 mmHg at 1 and 3 months, respectively (P \ 0.0001 vs baseline). Target BP was achieved by 49.2% and 86.7% of patients at 1 and 3 months, respectively. Reductions in mean number of angina attacks and nitrate consumption and improvements in heart rate were statistically significant. Treatment was well tolerated. Conclusion: Treatment of patients with hypertension and CAD with Bis/Per SPC for 3 months was associated with significant decreases in SBP/ DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by an improvement in angina symptoms. Treatment was well tolerated in a broad patient population representative of those seen in everyday clinical practice.

Effectiveness and Tolerability of Bisoprolol/Perindopril Single-Pill Combination in Patients with Arterial Hypertension and a History of Myocardial Infarction: The PRIDE Observational Study

“…The PRIDE results complement the findings from the Canadian observational studies by providing data with a bisoprolol/perindopril SPC. The PRIDE design was similar to that of the STYLE study, also conducted in Russian clinical practice, with the exception that all patients had a history of previous MI, compared with only 26% in the STYLE study [ 20 ]. Both studies demonstrated statistically significant reductions in blood pressure from as early as 4 weeks after the initiation of the SPC, with continued improvements throughout the study.…”

“…Recent real-world data have confirmed the antihypertensive and antianginal benefits of a bisoprolol/perindopril combination in patients with hypertension and stable CAD [ 20 , 21 ]. The aim of the current observational study was to extend the previous observational data by evaluating the effectiveness of a beta-blocker-based SPC on blood pressure, heart rate, and anginal symptoms in a high-risk post-MI population with concomitant hypertension.…”

Concomitant Treatment of Hypertensive Patients with Bisoprolol and Perindopril in Routine Clinical Practice: A Post Hoc Analysis of the CONFIDENCE II, PROTECT I, and PROTECT III Observational Studies

“…Real-world data on the benefits of using a bisoprolol/perindopril SPC in patients with hypertension and stable CAD (previously treated with bisoprolol with or without concomitant perindopril) were obtained from two recent open-label, prospective, observational studies [ 33 , 34 ]. Patients were treated with SPC for 1 month ( n = 2394) and 3 months ( n = 1892), respectively.…”

Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) scientific statement on the simplification of the drug regimen for secondary cardiovascular prevention

“… 21 In two prospective observational studies, the bisoprolol/perindopril SPC in patients with hypertension, stable angina, and/or previous MI was associated with a significant reduction in blood pressure and an improved angina threshold. 22 , 23 An Italian study including over 18 800 patients with newly diagnosed hypertension and on antihypertensive drugs found that combination therapy was associated with greater therapeutic adherence, and a high adherence (defined again as >80% of days on treatment) reduced the risk of cardiovascular events during a mean follow-up of 4.6 years. 24 In the recent START study, an SPC strategy with four drugs increased therapeutic adherence and reduced MACE and all-cause mortality compared with the same drugs given separately.…”